The EMA has produced a further draft of the policy which would introduce barriers to access to clinical trial data that would make the job of researchers who want to scrutinise it almost impossible.

The policy introduces terms of use which say that researchers can access the data on screen only with printing, sharing or saving of the data forbidden.

It allows the company who supplied the data to the EMA to decide which information to redact so researchers may never know what information is being kept hidden.

The EMA's draft policy also asks researchers to agree that the companies who produced the trial data can take legal action directly against the researchers if the trial sponsor considers the researchers broke any of the conditions, introducing a new and unpredictable risk of high legal costs into routine academic work.

The volunteers who take part to clinical trials put their own life at risk of unexpected adverse drug reactions. They do so to contribute to scientific progress for the benefit of society. Therefore the results of the trials belong to them and to society at large . Everybody has the right to access the evidence used by EMA scientific committees to determine the benefits and risks of medicines.

Despite that public-spirited risk-taking by volunteers, pharmaceutical companies are trying to claim the resulting data as "commercially confidential information" that belongs exclusively to them, not to society. The BEUC letter ends by posing an interesting question:

we take this opportunity to ask you to clarify the impact -- if any -- of the settlement with AbbVie on the definition of the new policy.

from the consistent-inconsistency dept

It should be clear by now that Apple sees most of us as the proverbial unwashed masses and is on something of a mission to immolate immoral thought patterns by trying to put everyone's head in the collective sand. That seems to be the only explanation for their app store censoring process, which has in the past removed historical context from games, the human body from consideration, comic books it deems to be immoral, and literature. All, mind you, in the name of a corporate moral code that probably wouldn't hold up under closer scrutiny.

But even if Apple wants to play the morality card, it presents the problem of consistency. Moral stances, after all, don't allow for picking and choosing due to outside factors. Yet that appears to be exactly what is occurring with the latest app store nixing of a popular game about growing marijuana, called Weed Firm.

As you might have noticed the game is no longer available on the Apple App Store. This was entirely Apple's decision, not ours. We guess the problem was that the game was just too good and got to number one in All Categories, since there are certainly a great number of weed based apps still available, as well as games promoting other so-called 'illegal activities' such as shooting people, crashing cars and throwing birds at buildings...If we let hypocrites determine what content is suitable for us we will soon all be watching teletubbies instead of Breaking Bad and playing... oh I don't know… nothing good comes to mind, without some form of 'illegal activity' or other really.

A couple of things to note. First, for those of us that are older than, say, fifteen, the rapid decriminalization of all things marijuana in this country is on a pace that can be described as no less than staggering. If you simply chart out what's gone on over the past decade and extrapolate into the next, it isn't off base to expect marijuana to go the way of tobacco and alcohol within that time. So the morality play is on shaky ground to begin with. Add to that, as Kotaku does, that the only thing consistent about Apple's app removal standards is its astounding inconsistency, and we should probably all begin asking ourselves exactly what the point of any of this is.

You can find places to buy weed on the app store. You can rate different strains of weed. You can download apps that teach you more about marijuana, or get apps that will give you various cosmetic weed changes to your phone. You can even roll fake joints. You can't, however, download a game where you grow marijuana. Other games, such as Weed Farmer and Weed Tycoon, remain active on the app store for now—but these games weren't as popular or as well-rated as Weed Firm was.

What, on the face of it, might have appeared to be a genuine, if misplaced, attempt to apply some kind of moral code suddenly dissolves into a PR response. As long as the marijuana-related games are generating money without being popular enough to draw any kind of wider attention, Apple's moral qualms go by the wayside. They either don't have the interest or the actual capacity to actively police all such offending games. Either answer renders the morality play moot to begin with: either you can enforce your strict guidelines in general or you can't. Apple, in the case of games revolving around marijuana, clearly can't. So what are we all doing here?

Well, we're suffering under Apple's delusion that we're children, of course. Children in need of a firm hand and the guidance of our parents, which apparently somehow became Apple. I suppose it isn't all that different from the old AOL walled-internet days, which I happily note went the hell away over a decade ago when the internet and its average denizen grew up. Maybe it's time now for Apple to stop it with the whole Puritan routine and start trusting their customers a bit more?

from the urls-we-dig-up dept

Concern over antibiotic resistance seems to be steadily growing, but some folks are optimistic that science will be able to develop new drugs or other kinds of medicines to replace older, increasingly ineffectual, pharmaceuticals that target the microbes in our bodies. Considering that scientists have only recently started to study the human microbiome, it's possible that medicine could find a whole new categories of treatments that are yet undiscovered. Here are just a few links on finding drugs all around us.

from the urls-we-dig-up dept

There are a lot of myths and aphorisms about the passage of time. A watched kettle never boils. Time flies when you're having fun. However, these observations could lead to some important discoveries about human psychology and how our brains perceive and remember various events in our lives. Does "proportionality theory" really explain why 8yo kids and 80yo senior citizens judge time differently? Here are just a few links on the topic of time.

from the if-you-don't-like-punishment,-don't-not-break-the-rules dept

Live a clean life and the cops should leave you alone, right? RIGHT?!? Harvey Silverglate wasn't being facetious when he wrote "Three Felonies A Day." There are all sorts of laws waiting to be broken, laws that boggle the mind in their insipidity.

As we covered recently, the FBI arrested one of its own handcrafted "terrorists" for "conspiring" to materially aid a terrorist organization. This "conspiring" apparently took the form of the suspect talking about possibly joining a terrorist group and, with undercover agents' urging, traveling to Canada to fill out some sort of terrorist job application. He was arrested at the border, having really done nothing more than talk big and wear the "rube" label really well.

More recently, Techdirt covered Judge Otis Wright's beration of the ATF for setting up stooges to pull off a fake crime -- a conspiracy to rob a "stash house." Of course, the stash house didn't exist, but this didn't stop the government from bringing criminal charges against the "criminals" and seeking sentences based on the entirely fictional contents of the fictional house. The ATF told its stooges that the house contained 20-25 kilos of coke in the house. Judge Wright asked why not just say 10, or 100 or 1,000, as long as the government's just making up numbers? No crime here because said "stash house" simply didn't exist and yet, people were arrested and put on trial.

Deputies said they stopped Delbert Dewayne Galbreath at NW 10th Street and Interstate 44 for a broken brake light. The deputy said Galbreath admitted he did not have a license to drive. Two deputies asked to search his car and he agreed.

A deputy found a cigarette pouch that had 16 pieces of a rock-like form, which authorities generally associate as crack cocaine. The deputies said they also found a digital scale.

Authorities tested the rocks and said they did not contain cocaine. When they asked Galbreath what the rocks were, he said they were Scentsy. Galbreath was arrested on suspicion of possession with intent to distribute imitation controlled dangerous substance (CDS), possession of drug paraphernalia, driving under a revoked license and defective equipment.

Read that again: a man was arrested for not possessing drugs. Note the oddly specific denial. The man said they were "Scentsy." This doesn't sound like someone just blurting out the first thing that came to mind when deputies searched his vehicle.

If you're not familiar with Scentsy, it's a direct marketing company that specializes in "wickless candles," which are scented wax cubes that are warmed on its proprietary warmers. (All images taken from Scentsy's catalog unless otherwise noted)

Here's how the process works.

Here's a shot of a couple of Scentsy cubes sitting in a warmer with a vaguely scale-like shape.

Here's some more scale-esque warmers Scentsy offers.

And here's another scale-like warmer that's included in every Scentsy starter kit.

And here's some vaguely crack-colored wax sitting in a Scentsy warmer.

And for comparison's sake, here's a DEA file photo of crack cocaine.

So, this seems like an entirely plausible explanation. The plausibility factor shoots way up when you factor in the negative test results. But rather than investigate whether Galbreath's claims were accurate after the "NOT COCAINE" determination, the deputies ran with their original plan: nail Galbreath for drug dealing. Instead of dealing drugs, Galbreath was trying to sell fake drugs, which is completely indistinguishable from actual criminal activity when you're sitting in a jail cell.

Maybe the Sheriff's Dept. is hoping to sweat out some more info from the jailed "dealer," like who his pissed off customers are or who's further up the chain supplying him with fake drugs and taking a percentage of each sale he makes. (My hunch? A regional director in Oklahoma as well as any number of intermediaries along the direct marketing food chain.)

"Don't do the crime if you can't do the time," they say. But they somehow fail to add, "Don't NOT do the crime if you can't do the time," because everyday citizens like you and me might find that statement baffling, horrifying and complete bullshit.

from the refreshingly-honest dept

We've covered the continuing efforts of emergingeconomies to provide key medicines for their populations at affordable prices. To do that, they often invoke their right to use compulsory licensing to bring down costs. For understandable reasons, the big pharma companies aren't happy with that approach, but usually dress it up as a concern about the supposed threat to "innovation" that it represents -- their claim being high prices are needed to fund expensive research. But as Techdirt has noted, pharma's estimates of expenditure here tend to be hugely inflated, which rather undercuts that argument.

"We did not develop this medicine for Indians," Dekkers said Dec. 3. "We developed it for western patients who can afford it."

That's a refreshingly honest admission that rather than wanting to save lives around the world, what Bayer is interested in is maximizing its profits by selling expensive drugs to "western patients who can afford it," and that those who can't pay can just, well, drop dead -- which, of course, is precisely what many of them will do without Bayer's drugs.

Some might say that's a perfectly reasonable position -- after all, Bayer and the other pharmaceutical companies are for-profit concerns. But they weren't always so dismissive of humanitarian concerns. Here's what George Merck, who became president of his father's eponymous chemical manufacturing company in 1929, said on the subject, as quoted on the Today in Science History site:

We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

from the a-vulgar-display-of-power dept

This post is going to be very short on commentary because the hideous abuse of justice has basically rendered me near speechless.

David Eckert, a resident of Deming, NM, was pulled over by police officers after failing to come to a complete stop at a stop sign. For whatever reason, the officers decided Eckert was hiding something, or perhaps they were unsatisfied that a routine stop hadn't blown up into something bigger.

They asked him to step out of the car and then searched his vehicle (without his consent). Another officer brought in a drug dog which reacted (a relatively worthless indication of anything -- drug dogs can easily be "alerted" by their controlling officers) to the driver's seat. (Eckert's lawyer calls into question this dog's training, presenting documents that claim to show it hadn't received the proper field training and recertification. See exhibits listed under docket item 27.) Then the officer "observed" that Eckert was standing "erect with his legs together" and his "buttocks clenched." This was all the justification the Deming police needed to subject Eckert to the following horrific chain of events at a hospital in neighboring Silver City.

1. Eckert's abdominal area was x-rayed; no narcotics were found. 2. Doctors then performed an exam of Eckert's anus with their fingers; no narcotics were found. 3. Doctors performed a second exam of Eckert's anus with their fingers; no narcotics were found. 4. Doctors penetrated Eckert's anus to insert an enema. Eckert was forced to defecate in front of doctors and police officers. Eckert watched as doctors searched his stool. No narcotics were found. 5. Doctors penetrated Eckert's anus to insert an enema a second time. Eckert was forced to defecate in front of doctors and police officers. Eckert watched as doctors searched his stool. No narcotics were found. 6. Doctors penetrated Eckert's anus to insert an enema a third time. Eckert was forced to defecate in front of doctors and police officers. Eckert watched as doctors searched his stool. No narcotics were found. 7. Doctors then x-rayed Eckert again; no narcotics were found. 8. Doctors prepared Eckert for surgery, sedated him, and then performed a colonoscopy where a scope with a camera was inserted into Eckert's anus, rectum, colon, and large intestines. No narcotics were found.

At no time did Eckert give his consent to these searches. The police did obtain a warrant to rectally search Eckert but that warrant itself was problematic. For one, it was severely lacking in probable cause. For another, it was valid only for Luna County but the searches were executed in Grant County. Third, the warrant was only valid for four hours, up until 10 pm that night. Eckert was held for 14hours and, according to medical records, prep for the colonoscopy didn't even commence until 1 am the following day.

Why the venue shift? Because the doctor at the Deming hospital told officers the proposed search was "unethical." Drs. Robert Wilcox and Okay Odocha of the Gila Regional Medical Center apparently had no qualms about forcibly "searching" Eckert eight times.

There's more in Eckert's complaint, including the fact that the second x-ray was of his chest, an area completely unrelated to the region where he was supposedly "concealing drugs." In addition to what can be proven from medical records and police reports obtained by Eckert's attorney, there are additional allegations that the officers Chavez and Hernandez mocked him and made derogatory comments about his "compromised position." They also allegedly moved the privacy screen repeatedly to expose him to others in the hospital hallway. This verbal abuse apparently continued during Eckert's ride back to the Deming police station. Understandably, Eckert now claims to be "terrified to leave the house" and does so "infrequently."

There are many lawsuits filed where most details are alleged. This isn't one of them. Most of what's "alleged" by Eckert is documented by the routine paperwork that accompanies medical procedures and search warrants. And, to add insult to injury, KOB4's news team states that the Gila Regional Medical Center is billing Eckert for the invasive, non-consensual medical procedures and has threatened to take him to collections for non-payment.

The only question that remains is why no one involved on the "law" side ever thought that anything past the first step on the list above might be excessive. These officers, along with two shamefully compliant doctors, went as far as they could to humiliate and violate someone simply because they could -- in a collective effort that looks far more like making Eckert pay for the "crime" of making the cops look stupid than any sort of legitimate law enforcement effort.

from the urls-we-dig-up dept

Some people really enjoy exercising. Some people really don't. And some people have physical limitations that restrict the amount or kinds of exercise they can do. If there were a pill that could provide some of the benefits of exercising, plenty of folks would take it. Not surprisingly, a lot of research is looking at how exercise affects the body -- and some projects might lead to a pharmaceutical solution for couch potatoes. Here are just a few examples.

from the urls-we-dig-up dept

Making the perfect cup of coffee is an experiment that's been studied for decades -- if not for hundreds of years since coffee was first brewed in the 1300s. It's not an exact science yet, but studies on coffee drinking seem to point to it being mostly beneficial. Here are just a few interesting links for coffee lovers out there.

from the no-surprise-there dept

A couple of years ago, Techdirt carried an article by Andy Kessler about the difference between entrepreneurs who create value, and those who lock it up. The former tend to drive prices down constantly, innovating all the while in order to make a profit; the latter, by contrast, typically enjoy monopolies that allow them to push up prices without offering anything more in return.

Here's another great example of the latter from The New York Times, which concerns so-called "orphan drugs" -- that is, those intended to treat more uncommon diseases, which are often overlooked by Big Pharma only interested in Big Markets and Big Profits. Here's what happened with a company called Jazz:

To get drug developers to focus on these relatively small pools of patients, the federal government offers inducements like a 50 percent research-and-development tax credit as well as a longer period of market exclusivity (seven years after Food and Drug Administration approval, rather than the typical five). These long monopolies often give orphan drug makers a free hand to raise prices.

That's precisely what Jazz has done, often multiple times each year, at an average annual rate of nearly 40 percent. Today, Xyrem costs more than $65,000 per year for the typical user.

Of course, the standard justification for such incredibly expensive drugs is that they are incredibly expensive to develop. Techdirt has debunked that notion in general, and The New York Times article does so again for this particular case:

Xyrem, which is a modification of a long-available compound, was inexpensive to develop, as new drugs go. Indeed, Jazz paid only $146 million for Orphan Medical [the company that did the original work on Xyrem and other orphan drugs], just a fraction of what it now earns each year from Xyrem alone. (The company contends that it has spent considerably on its development.)

So however laudable the aim of the 1983 Orphan Drug Act might have been, its effect can turn out to be just what you would expect from granting yet more government-backed monopolies: ever-higher prices for no additional benefit -- the very definition of a company locking up value, rather than creating it.